Integrated device and system for remote medications management

ABSTRACT

The presently disclosed device includes a plurality of vials each bearing a unique identifier and in discrete locations in the device. An alignment assembly aligns one of the discrete locations with an access point for dispensing one of the vials. Computer executable instructions select a vial to be dispensed and store inventory information of the vials. The inventory information associates the unique identifiers with a status for each the plurality of vials indicating whether a vial is: loaded, dispensed, returned, or remaining undispensed in the device. The computer executable instructions also deactivate dispensing of the vials from the device based on at least one signal received from at least one environmental sensor configured to detect one of: location, temperature, humidity, vibration, shock, blood alcohol content (BAC), and light intrusion. A deactivation assembly deactivates dispensing of the vials based on the instructions.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 17/822,001 entitled “Integrated Device and System for DrugDispensing,” which was filed on Aug. 24, 2022, which is acontinuation-in-part of U.S. patent application Ser. No. 17/245,028entitled “Integrated Device and System for Drug Dispensing,” which wasfiled on Apr. 30, 2021, which is a continuation-in-part of PCT PatentApplication No. PCT/US2019/058967 entitled “AN INTEGRATED DEVICE ANDSYSTEM FOR DRUG DISPENSING,” which was filed on Oct. 30, 2019, whichclaims benefit of and priority to U.S. Provisional Patent ApplicationNo. 62/752,392 entitled “INTEGRATED DEVICE AND SYSTEM FOR DRUG DETECTIONAND DEACTIVATION TO DETER CONTROLLED SUBSTANCE THEFT IN HOSPITALS ANDOTHER HEALTHCARE DELIVERY SETTINGS,” which was filed on Oct. 30, 2018,the contents of all of which are incorporated by reference herein.

TECHNICAL FIELD

The present invention relates to systems, methods, and devices remotemedications management.

BACKGROUND

Controlled substance drugs (CS drugs) are those subject to restrictionson distribution, dispensing, and disposal by government agencies.

For example, without limitation, such restrictions apply to manytherapeutic products for which the US Food and Drug Administration's(FDA) requires a prescription for dispensing. Additionally, the underthe authority of The Controlled Substances Act places allpharmaceuticals products into one of five schedules. Pharmaceuticals arescheduled as a CS if they have “potential for abuse”, as indicated by:evidence that individuals are taking the drug such that it is a hazardto themselves or others; significant diversion from legitimate drugchannels; individuals taking the drug without medical advice; or, a newdrug or drug in testing with similar pharmacology to a drug having abusepotential. Included in the most restrictive Schedule II category arenarcotic analgesics, prescriptions for which must be written and signedby the practitioner and may not be refilled.

Moreover, restrictions on distribution, dispensing, and disposal applyto investigational new drugs in clinical testing. For example, aclinical investigator may administer such drug only to subjects underthe investigator's personal supervision or under the supervision of asubinvestigator responsible to the investigator, and the investigatormay not supply the investigational drug to any person not authorized toreceive it.

The distribution and dispensing of cannabis, whether legal forrecreational use, medicinal use, or both, is controlled by governmentagencies.

Medicated-Assisted Treatment (MAT) is the use of FDA-approvedmedications, often in combination with counseling and behavioraltherapies, to provide a “whole-patient” approach to the treatment ofsubstance use disorders. Two medications (methadone and buprenorphine)commonly used to treat opioid addiction are CS drugs, themselves. It isdesirable and sometimes required by law that the license medicalpractitioner who provides MAT do so in a “qualified practice setting.” Aqualified practice setting is one that ideally provides: professionalcoverage for patient medical emergencies during hours when thepractitioner's practice is closed; access to case-management servicesfor patients including referral and follow-up services, such as medical,behavioral, social, housing, employment, educational, or other relatedservices; uses health information technology systems such as electronichealth records; and, is registered for their US State prescription drugmonitoring program (PDMP) where operational and in accordance with USFederal and State law.

Many patients may not qualify for at-home dispensing of controlledsubstances. For example, a patient may live in a group home, or haveseveral children at home, and the patient may be a new patient and lacka history of successful at-home dosing. A lack of physical security atthe home where people other than the patient may try and access thecontrolled substance may dissuade a clinic from allowing at-homedispensing of the controlled substance for that patient. In anotherexample, an older patient may be forgetful about taking the controlledsubstance or physically securing the controlled substance usingconventional methods. Again, a clinic may be dissuaded from allowingat-home dispensing for such a patient. A disadvantage of current systemsfor dispensing controlled substances is that each clinic can onlysupport a certain number of in-person patients. Yet patients who mayotherwise qualify for at-home dosing may not allowed at-home dispensingdue to clinic concerns of potential abuse.

It desirable that access to outpatient care, including in home settings,qualify for some or all the ideal aspects of a qualified practicesetting given above. Accordingly, there remains a need to address thesedisadvantages and others not described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments are illustrated by way of example and are notintended to be limited by the figures of the accompanying drawings. Inthe drawings:

FIG. 1 depicts a network-enabled lockbox for remote medicationsmanagement to an embodiment of the subject matter described herein;

FIG. 2 depicts a network-enabled lockbox for remote medicationsmanagement including dispensing a substance with the lid open therebyexposing the top plate where all dispensing lids are in a closedposition according to an embodiment of the subject matter describedherein;

FIG. 3 depicts the top plate of the network-enabled lockbox for remotemedications management in greater detail according to an embodiment ofthe subject matter described herein;

FIG. 4 depicts the network-enabled lockbox assembly of FIG. 3 with thecarousel cover and the static dose dispensing lid removed according toan embodiment of the subject matter described herein;

FIG. 5 depicts a perspective view of the network-enabled lockboxassembly of FIG. 3 with the entire top plate removed thereby exposingthe subdivided interior portions of the assembly according to anembodiment of the subject matter described herein;

FIG. 6 depicts a perspective view of the carousel, motor, and worm driveassembly connected to an interior frame where the assembly is loadedwith doses and a static dose according to an embodiment of the subjectmatter described herein;

FIG. 7 depicts a perspective view of an empty carousel, motor, and wormdrive without an internal frame according to an embodiment of thesubject matter described herein;

FIG. 8 depicts an exploded perspective view of an alternativeconfiguration of an empty carousel, motor, and worm drive without aninternal frame according to an embodiment of the subject matterdescribed herein;

FIG. 9 depicts a network diagram illustrating exemplary communicationsbetween devices according to an embodiment of the subject matterdescribed herein;

FIG. 10 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary activity tiles design for an administrative dashboardaccording to an embodiment of the subject matter described herein;

FIG. 11 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary click-through result from the “Create Patient Profile”activity tile of FIG. 10 according to an embodiment of the subjectmatter described herein; and

FIG. 12 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary reporting, analytics, and administrative functions accordingto an embodiment of the subject matter described herein.

The same reference numbers and any acronyms identify elements or actswith the same or similar structure or functionality throughout thedrawings and specification for ease of understanding and convenience.

DETAILED DESCRIPTION

Techniques are disclosed for secure dispensing of substances, such ascontrolled substances. As used herein, a “controlled substance” isviewed broadly and refers to any drug or other substance that iscontrolled by a government agency. Certain such controlled substancesmay be more tightly controlled because they may be abused or causeaddiction. The control applies to the way the substance is made, used,handled, stored, and distributed. Controlled substances include opioids,stimulants, depressants, hallucinogens, and anabolic steroids.Controlled substances with known medical use, such as methadone,morphine, Valium, and Ritalin, are available only by prescription from alicensed medical professional. Likewise, drugs under clinicalinvestigation are controlled and considered herein as controlledsubstances.

The presently disclosed device includes a plurality of vials eachbearing a unique identifier and in discrete locations in the device. Analignment assembly aligns one of the discrete locations with an accesspoint for dispensing one of the vials. Computer executable instructionsselect a vial to be dispensed and store inventory information of thevials. The inventory information associates the unique identifiers witha status for each the plurality of vials indicating whether a vial is:loaded, dispensed, returned, or remaining undispensed in the device. Thecomputer executable instructions also deactivate dispensing of the vialsfrom the device based on at least one signal received from at least oneenvironmental sensor configured to detect one of: location, temperature,humidity, vibration, shock, and light intrusion. A deactivation assemblydeactivates dispensing of the vials based on the instructions.

In one embodiment, a network-enabled lockbox for remote medicationsmanagement includes a wireless communication device, one or moresensors, and a rotating carousel containing one or more doses of thesubstance. The carousel is configured to provide a dose of the substanceduring a preconfigured period of time. The one or more sensors areconfigured to detect one or more alert conditions. The wirelesscommunications are configured to wirelessly communicate informationbetween the network-enabled lockbox and a remote server. Detecting analert condition may be configured to cause an alarm condition to beregistered on the remote server. Detecting an alert condition also maybe configured to disable the lockbox dispensing function, either localand autonomously or in response the remote server having registered analarm condition. In another embodiment, dispensing functions of anetwork-enabled lockbox are disabled by a signal initiated manually atthe remote server.

In another embodiment, a network-enabled lockbox for remote medicationsmanagement includes an outer compartment, an interior frame insertedinto the compartment and secured to the compartment, a top plate, a wormdrive, an electric motor connected to the worm drive, controlelectronics for controlling the motor, a carousel connected to the wormdrive, a plurality of sensors, and a communications subsystem forcommunicating data to a backend server.

The outer compartment includes a body and a lid pivotably coupled to thebody for selectively opening the compartment, where a space enclosed bythe compartment is physically secured with a lock built-in to thecompartment or attached with security screws that cannot be removed fromthe exterior of the lid or can only be removed with a special tool.

The interior frame includes a shield/divider for physically separating afirst portion of the space enclosed by the compartment from a secondportion of the space enclosed by the compartment. The interior frameincludes a static dose compartment includes four side walls for storinga static dose of the substance. The interior frame includes a motorhousing surrounding the motor and the worm drive for physicallyseparating and enclosing the motor and the worm drive in a third portionof the space enclosed by the compartment, wherein motor housing issecurely attached to the compartment.

The worm drive includes an input shaft and an output shaft. The inputshaft includes a cylinder having a spiral thread that engages with anddrives a toothed wheel. The output shaft includes a cylinder attached tothe toothed wheel, where the output shaft is connected to the carouselfor rotating the carousel. A gear ratio of the worm drive is configuredso that the direction of transmission between the input shaft and theoutput shaft is not reversible.

The electric motor is connected to the input shaft of the worm drive,the battery, and the control electronics, where the electric motor ispowered by the battery and drives the input shaft based on instructionsfrom the control electronics.

The carousel includes a top plate and a bottom plate, each plateincluding a circular disc of material. The bottom plate has an innerdiameter and an outer diameter where a solid material is located betweenthe inner and outer diameters. The bottom plate also has a plurality ofscrew holes for receiving a plurality of standoff screws that securelyattach the bottom plate to the top plate. The top plate has an innerdiameter and an outer diameter where a solid material is located betweenthe inner and outer diameters. The inner diameter is configured forreceiving the output shaft. The top plate includes a solid materiallocated between the inner and outer diameters. The top plate further hasa plurality of non-overlapping dispensing positions, where everydispensing position except one includes a hole for receiving a dose ofthe substance. The dispensing positions are equally spaced from eachother, the top plate also having a plurality of screw holes forreceiving a plurality of standoff screws for securely attaching the topplate to the bottom plate.

A battery is connected to the motor and other electronic components forproviding electrical power to the motor, the control electronics, thecommunications electronics, and the plurality of sensors. The battery isfurther connected to an input plug for receiving electrical power froman external power source.

A communications subsystem communicates data between the plurality ofsensors and/or the control electronics and a backend server and/or amobile device. The communications subsystem includes a Wi-Fi device forcommunicating with nearby digital devices to exchange data by radiowaves via IEEE 802.11 wireless network protocols. The communicationssubsystem also includes cellular radio for communicating wirelessly withcellular network towers. The communications subsystem also includes aBluetooth device for exchanging data between over short distances usingUHF radio waves in the ISM bands from 2.402 GHz to 2.48 GHz.

Control electronics are connected to the battery for controlling themotor. The control electronics include a memory and a processor forstoring and executing instructions. The instructions can be configuredlocally or remotely.

A plurality of sensors is connected to one or more of the controlelectronics, the communications subsystem, and the battery. Theplurality of sensors include at least one of: a location sensor fordetermining a location of the network-enabled lockbox, wherein thelocation sensor includes a global positioning system (GPS) device; atemperature sensor for measuring a temperature of at least one of avolume of air or a physical component of the network-enabled lockbox; ahumidity sensor for detecting and measuring water vapor within a volumeof air; an accelerometer for measuring a rate of change of a velocity ofthe network-enabled lockbox; a visual sensor, wherein the visual sensoris a camera; an audio sensor, wherein the audio sensor is a microphone;and a plurality of proximity sensors for detecting presence of nearbyobjects without physical contact. The plurality of proximity sensorsinclude at least one of: a first access port sensor for sensing whetherthe first access port lid is in an open position or a closed position; asecond access port sensor for sensing whether second access port lid isin an open position or a closed position; a top cover sensor for sensingwhether the top cover is in an open position or a closed position; a lidlock sensor for sensing whether the lid is in a locked position or anunlocked position; and a top cover lock sensor for sensing whether thetop cover is in a locked position or an unlocked position. The one ormore of the proximity sensors includes a magnetic contact sensor that isconfigured to identify the closed position or the locked position when amagnetic field is above a threshold value and to identify the openposition or an unlocked position when the magnetic field is below athreshold value.

A top cover covers the carousel, the interior frame, the worm drive, themotor, the battery, the control electronics, and the communicationssubsystem and the top cover is securely attached to the compartment. Thetop cover includes a first access port comprising a first opening in thetop cover and a first access port lid pivotably coupled to top cover andcovering the first opening, wherein the first access port is alignedwith one of the dispensing positions. The top cover includes a secondaccess port comprising a second opening in the top cover and a secondaccess port lid pivotably coupled to top cover and covering the secondopening, wherein the second access port is aligned with an open portionof the static dose compartment.

Among other advantages, embodiments disclosed herein enable for remotemonitoring and control of the dispensing of substances, especiallycontrolled substances. This allows more patients to receive theirmedications at home without going into a clinic or dispensary in personwithout introducing unwanted security risks including, but not limitedto, physical security of the controlled substance doses from tamperingby persons other than the patient and overdosing.

In an exemplary embodiment, the network-enabled lockbox is an Internetof Things (IoT)-enabled dispenser designed to hold controlled substancemedications. The dispenser has imbedded LTE-M radio and communicateswith a remote software application hosted in the cloud. The dispenserhas autonomous logic on-board to execute patient dosing orders even whennot connected to the remote application.

The dispenser has physical dimensions: height, width, length, andweight. The dispenser consists of a bottom that holds medications andelectronics, which are hidden with a lockable top plate. The top of thedispenser is connected via hinges to the bottom of the dispenser andcontains a 4-digit combination lock.

Inside the dispenser, the top plate includes a button, a display, andhole for taking one scheduled dose from the dispenser compartment whichis covered by a door, opening or closing of which is detected by asensor. Inside the dispenser is also a dispenser compartment for takingan unscheduled safety or static dose, which may be the last dose of acycle but can also be an emergency or safety dose, which is covered by asensored cover.

Device capacity is 13 doses (up to 12 doses in the carousel and onestatic dose. A rotating carousel inside the dispenser can have one blankposition which can be filled with a stub. The blank position, ifconfigured, can be exposed: after the device refilled, before the firstdose, and/or between doses. For maintenance purposes (e.g., filling thedispenser), the top cover can be opened. Main functions of the dispenserinclude: physical security and control of medication,provider-determined remote medication dosing protocol, and nearreal-time medication usage and inventory.

The following description and drawings are illustrative and are not tobe construed as limiting. Numerous specific details are described toprovide a thorough understanding of the disclosure. However, in certaininstances, well-known or conventional details are not described in orderto avoid obscuring the description. References to one or an embodimentin the present disclosure can be, but not necessarily are, references tothe same embodiment; and such references mean at least one of theembodiments.

Reference in this specification to “one embodiment” or “an embodiment”means that a particular feature, structure, or characteristic describedin connection with the embodiment is included in at least one embodimentof the disclosure. The appearances of the phrase “in one embodiment” invarious places in the specification are not necessarily all referring tothe same embodiment, nor are separate or alternative embodimentsmutually exclusive of other embodiments. Moreover, various features aredescribed which may be exhibited by some embodiments and not by others.Similarly, various requirements are described which may be requirementsfor some embodiments but not other embodiments.

The terms used in this specification generally have their ordinarymeanings in the art, within the context of the disclosure, and in thespecific context where each term is used. Certain terms that are used todescribe the disclosure are discussed below, or elsewhere in thespecification, to provide additional guidance to the practitionerregarding the description of the disclosure. For convenience, certainterms may be highlighted, for example using italics and/or quotationmarks. The use of highlighting has no influence on the scope and meaningof a term; the scope and meaning of a term is the same, in the samecontext, whether or not it is highlighted. It will be appreciated thatsame thing can be said in more than one way.

Consequently, alternative language and synonyms may be used for any oneor more of the terms discussed herein, nor is any special significanceto be placed upon whether or not a term is elaborated or discussedherein. Synonyms for certain terms are provided. A recital of one ormore synonyms does not exclude the use of other synonyms. The use ofexamples anywhere in this specification including examples of any termsdiscussed herein is illustrative only and is not intended to furtherlimit the scope and meaning of the disclosure or of any exemplifiedterm. Likewise, the disclosure is not limited to various embodimentsgiven in this specification.

Without intent to limit the scope of the disclosure, examples ofinstruments, apparatus, methods and their related results according tothe embodiments of the present disclosure are given below. Note thattitles or subtitles may be used in the examples for convenience of areader, which in no way should limit the scope of the disclosure. Unlessotherwise defined, all technical and scientific terms used herein havethe same meaning as commonly understood by one of ordinary skill in theart to which this disclosure pertains. In the case of conflict, thepresent document, including definitions will control.

As used herein, an article is a physical object on which a label may beapplied. Examples of articles would include a vial, a capsule, a solidoral dosage form, a prefilled syringe, personal property, electronics,etc.

As used herein, a vial is an article that may be used to hold a physicalobject, a plurality of physical objects, or a liquid. A vial may becapped or otherwise sealed, uncapped or unsealed. “Vials” also may beremovable cups whether capped, sealed, or unsealed.

FIG. 1 depicts a network-enabled lockbox 100 for remote medicationsmanagement according to an embodiment of the subject matter describedherein. The network-enabled lockbox 100 is shown in a closed and fullysecured position. The network-enabled lockbox 100 includes an outercompartment, shell, or case including a body 102 and a lid 104. The lid104 is pivotably coupled to the body 102 for selectively opening thecompartment 100. An interior space enclosed by the compartment isphysically secured with a keyless lock 106 built-in to the body 102. Thelock 106 may be an alphanumeric combination lock, a biometric lock, or anetwork-enabled lock that communicates via Bluetooth with an authorizedand authenticated mobile device. The body 102 and the lid 104 may becomposed of a solid material, such as metal or plastic, for physicallyobscuring and securing the contents therein. Additionally, the body 102and the lid 104 may provide temperature and humidity control to thecontents therein both for protecting the integrity of the controlledsubstance doses and the various electronics and communications equipmentstored therein.

FIG. 2 depicts a network-enabled lockbox for remote medicationsmanagement with the lid open and all dispensing lids in a closedposition according to an embodiment of the subject matter describedherein. For example, once a user successfully opens the built-in lock106, the lid 104 may pivotably hinge and expose an interior of the case.As shown in FIG. 2 , all dispensing lids are in a closed position. Thismay occur because the time at which the lid 104 is opened was not duringa preconfigured dispense window (DW). A dispense window is a period oftime, such as ten minutes from 8:00 am until 8:10 am each day, duringwhich a dose or vial of the controlled substance is configured to bemade available to the user. The DW may be configured to remain opencontinuously. Outside the DW, the primary access port lid is closed andinside the DW the primary access port lid is open. The DW may bedetermined when the lockbox 100 is loaded and secured, for example at aclinic dispensary. The DW may be defined by a unit dispensing startdate, an interval in hours, a number of carousel slots filled withmedical doses, and a dosage window allotted time allocation in minutes.

A top cover 200 cover provides physical security to the contents of thelockbox 100 when the lid 104 is open. The top cover 200 is securelyattached to the compartment. For example, a plurality of screws mayattach the top cover 200 to various mounting points located on the body102. The top cover 200 may be composed of a solid material, such asmetal or plastic, for physically obscuring and securing the contentstherein. Alternatively, the top cover 200 may be composed of atransparent material to allow visibility to the contents.

FIG. 3 depicts the top plate of the network-enabled lockbox for remotemedications management in greater detail according to an embodiment ofthe subject matter described herein. The top cover 200 may be include acarousel cover 300 that is pivotably hinged using hinges 302 to the topcover 200 and secured with a lock 304. This allows an administrator toaccess the carousel (e.g., for repair or loading/unloading of vials)without removing the entire top plate 200. The top plate 200 may besecured to a box 304 via screws. The screws may be associated with oneor more sensors for detecting unauthorize attempts to remove the topplate.

The top cover 200 includes a first access port 308, also referred to asa primary dispensing door or main dispensing door, that includes a firstopening in the top cover 200 and a first access port lid pivotablycoupled to the top cover 200 that covers the first opening. The firstaccess port 308 is aligned with a dispensing position, which will bedescribed in greater detail below.

The top cover 200 also includes a second access port 310, also referredto as a static dose dispensing door, comprising a second opening in thetop cover 200 and a second access port lid that is pivotably coupled tothe top cover 200 and covers the second opening. The second access port204 is aligned with an open portion of the static dose compartment,which will be described in greater detail below.

The top cover 200 includes a dosing button (DB) 312. The dosing button312 is used to activate (e.g., unlock or open) the first access port lid308 during the DW (or the second access port lid 310 regardless of theDW). The dosing button 312 may incorporate colored lights and/orspeakers to indicate various states or conditions of the lockbox 100 tothe user. For example, if the top cover 200 is opened outside of the DW,the dosing button 312 color may be red. When the DW is reached, thelockbox 100 may play a sound and the dosing button 312 may be green.When the dosing button 312 is pressed, the motor may move the carouselto next position and the dosing button 312 may be blue. After dosing iscomplete and the first access port lid 308 is closed, power to thedosing button 206 may be reduced and/or the dosing button 206 may be orturned off.

The top cover 200 includes an information display screen 314 fordisplaying various notifications to the user. For example, if the topcover 200 is opened outside of the DW, the display screen 314 maydisplay a message such as “Next dosing is scheduled for 2021-09-13 6:00PM”. When the DW is reached, the display screen 314 may display: “Fornext dose, press the button”. When the dosing button 312 is pressed, thedisplay screen 314 may display: “Dose is ready, please take a dose”.When the patient removes the bottle of medicine from the lockbox 100(e.g., as detected by a first access port lid 308 sensor that assumesthe first access port lid closes after removing full bottle), a messagemay be displayed on the display screen 314: “Return empty dose and pushbutton to confirm”. Once the empty bottle is returned to the device(e.g., as detected by the first access port lid 308 sensor and confirmedwith the button), a message may be displayed on the display screen 314:“Dosing completed, please close and lock the lid”. After dosing iscomplete and the first access port lid 308 is closed, power to thedisplay screen 314 may be reduced and/or the display screen 314 may beor turned off.

Sensors:

The lockbox 100 may include a plurality of sensors. These sensors may bevariously connected to one or more of the control electronics, thecommunications subsystem, and the battery. The plurality of sensors caninclude: a location sensor for determining a location of thenetwork-enabled lockbox (e.g., a global positioning system (GPS)device), a temperature sensor for measuring a temperature of at leastone of a volume of air or a physical component of the network-enabledlockbox, a humidity sensor for detecting and measuring water vaporwithin a volume of air, an accelerometer for measuring a rate of changeof a velocity of the network-enabled lockbox, a visual sensor (e.g., acamera), an audio sensor (e.g., a microphone), and proximity sensors fordetecting presence of nearby objects without physical contact. Theproximity sensors may include: a first access port sensor for sensingwhether the first access port lid is in an open position or a closedposition, a second access port sensor for sensing whether second accessport lid is in an open position or a closed position, a top cover sensorfor sensing whether the top cover is in an open position or a closedposition, a lid lock sensor for sensing whether the lid is in a lockedposition or an unlocked position, and a top cover lock sensor forsensing whether the top cover is in a locked position or an unlockedposition. The proximity sensor may include a magnetic contact sensorthat is configured to identify the closed position or the lockedposition when a magnetic field is above a threshold value and toidentify the open position or an unlocked position when the magneticfield is below a threshold value.

It is appreciated that in addition to the humidity sensor for detectingand measuring water vapor within a volume of air may, the sensor canalso include a breathalyzer or similar device. A breathalyzer (aportmanteau of breath and analyzer) is a device for estimating bloodalcohol content (BAC), or to detect viruses or diseases from a breathsample. The diagnostic device estimates a person's BAC by blowing intothe device. When the user exhales into the breath analyzer, any ethanolpresent in their breath is oxidized to acetic acid at the anode,atmospheric oxygen is reduced at the cathode, and the overall reactionis the oxidation of ethanol to acetic acid and water. The electriccurrent produced by this reaction is measured by a microcontroller anddisplayed as an approximation of overall BAC.

The breathalyzer sensor may be used to allow or deny access to thelockbox 100. For example, a person with a BAC above a threshold amount(e.g., 0), as measured by the breathalyzer, may be automaticallyprevented from accessing the lockbox 100. Additionally, the results ofthe breathalyzer test may be automatically transmitted to a remoteserver to notify, for example, the person's doctor or other entity.Conversely, access to the lockbox 100 may be allowed if, as one of oneor more possible conditions, the user passes the breathalyzer test.

The lockbox 100 disclosed herein, being a physically and electronicallysecured medications management dispenser is an Internet of Things (IoT)connected device. In one embodiment, it is also linked via Bluetooth toa user's (e.g., a Veteran's) smart watch for monitoring vital signsrelevant to potential distress. The smart watch may also serve as aproximity sensor for locking out dispensing to unintended users. Asmentioned above, when the lockbox 100 is linked to a breathalyzer andalcohol use is above a critical threshold, medications will notdispense. If any distress is detected, the lockbox 100 can send “push”signals to a paired mobile device to automatically open apps, like aVeterans Crisis Line (VCL). Alternatively, a mobile device counselingsession may be required before unlocking medication dispensing. Lockbox100 status information, including user behavior associated withmedication dispensing requests may be communicated in real time viamobile network to cloud-based data management and analytics softwarewith dashboard presentation to caregivers.

The system disclosed herein can notify caregivers of acute suicide risk.To achieve this, the lockbox 100 may act as a local network hub formonitoring measures of a user's behavioral, physiological, and socialdeterminants of health and wellbeing associated with suicide risk. Inthe system, a smart watch can monitor user proximity to the dispenser,unlocking dispensing only when the user is nearby. The watch may alsomonitor physiologic markers like heartrate, oxygenation state (pO2),blood pressure (BP), and electrocardiogram (ECG). Since alcohol usewould contribute to the potential lethality of dispensed drugs, thesystem disclosed herein may be connected to a mobile breathalyzer,locking out drug dispensing above a pre-set blood alcohol level. Shouldany measure associated with acute suicide risk exceed a configurablepre-set threshold, the system disclosed herein may autonomously lock outdispensing and notify the user's caregiver to achieve intervention in aright-care, right-time, right-place approach. The triggering thresholdsmay be configured at different levels based upon a user's risk ofattempting suicide.

The system disclosed herein can improve access to suicide preventionresources by providing links to mobile technology and applications. Thisallows the system disclosed herein to integrate, in real time, withexisting digital health initiatives such as the VCL. Improving access tothe relevant resources is accomplished through “push” notifications to auser's mobile device triggered by specific events (e.g., high bloodalcohol content). The system disclosed herein also can trigger a “push”notification requiring a response before unlocking medications. Theserequired responses can be set to a recurring schedule or linked a simplesurvey question, like a mandatory yes vs. no answer to the question,“Have you had thoughts about taking your life?” A follow up connectionto VCL, including a counseling encounter, can also be configureddepending upon the response.

Finally, the system disclosed herein may collect conjoined passive dataabout a user's at-home use of medications and active physiological dataindicating an individual user's suicidality. The system disclosed hereinalso passively collects data about user's self-dosing behavior at home(e.g., time of day, frequency of requests, location, etc.) inconjunction with physiologic markers (e.g., heart rate, pO2, BP, BAC,screening questions), both baseline and as the user approaches thelockbox 100 anticipating drug dispensing. Evidence for alcohol use alsocan be measured in conjunction with other factors. Passive and activeconjoined data can further refine and individual user's suicide risk,yielding predictors of agitation, depression, suicidality, and otherrelevant risk factors.

Environmental sensors: Environmental sensors can detect temperature andhumidity, either absolute values or relative changes. This informationcan be reported to a back-end server as an “event” where an event mayoccur when the temperature and/or humidity detected by the environmentalsensors is outside of a threshold value or range. For example, beforestart of dosing, the device may send a “heartbeat” event (as discussedbelow) to the server to check if device is locked from server side.Environmental sensor data may also be sent from the device to the serverwith this event.

GPS: GPS can be configured to activate after a defined period of deviceload/reload. For example, a default value may be configured such as onehour. GPS can also be configured to send data to the server 902 atspecified intervals after the load/reload interval. Once an hour is alsothe default interval for GPS messages sent to the server. Once activeGPS sensing and message sending also occurs at the start and end of theDW If positions are available.

Accelerometer: This sensor may include an acceleration sensor and agyroscope sensor. The accelerometer may be active all the time. Theaccelerometer can detect free fall and shock to device. In case of oneor both of those events, the device can be automatically locked andreported to server. The device may stay locked until a remote unlocksignal is sent to the device from the server.

Intrusion sensor: If the dispenser is not in a load/unload state, theintrusion sensor can detect that the top plate 200 is removed from thedispenser. In this event, the device may send a message to the serverand lock the dispenser.

Static dose cover opening detection sensor: This sensor can detect thatthe static dose compartment 310 is opened and report event to theserver.

Lid opening sensor: This sensor can detect that the lid 102 is opened.In that circumstance the dispenser will report a “lid open” event toserver.

In summary, sensors on the lockbox 100 can include touch screen keypad(including single touch, multi-touch, gesture sensing in 2D or 3D,etc.), a physical keypad, a mouse, a pointer, a track pad, a stylus, astylus detector/sensor/receptor, motion detector/sensor (e.g., including1-axis, 2-axis, 3-axis accelerometer, etc.), a face detector/recognizer,a retinal detector/scanner, a light sensor, capacitance sensor,resistance sensor, temperature sensor, proximity sensor, a piezoelectricdevice, device orientation detector (e.g., electronic compass, tiltsensor, rotation sensor, gyroscope, accelerometer), or any combinationof the above.

Signals received or detected at the lockbox 100 through one or more ofthe above input mechanisms, or others, can be used in the disclosedtechnology in obtaining context awareness at the lockbox 100. Contextawareness at the lockbox 100 generally includes, by way of example butnot limitation, the lockbox 100 operation or state acknowledgement,management, user activity/behavior/interaction awareness, detection,sensing, tracking, trending, and/or application (e.g., mobileapplications) type, behavior, activity, operating state, etc. Contextawareness information may be sent to the back-end server on a predefinedschedule, or “heartbeat”. The heartbeat may contain some or all eventinformation or may be a single information packet designating no changein operation or state since last heartbeat.

Client-side software components can include software or agents installedon the lockbox 100 that enables and performs functionalities on thelockbox 100. The client-side software components can performadministrative functions such as receiving service requests and policyupdates from the server 902. Example client-side software components arediscussed below.

Device State Monitor: A device state monitor can be responsible foridentifying various states and metrics of the lockbox 100, such asnetwork status, display status, battery level, etc. such that otherclient-side software components can operate and make decisions accordingto the device state.

Reporting Agent: A reporting agent can gather information about theevents taking place in the lockbox 100 and send the information to thebackend server. Event details may be stored temporarily in the lockbox100 and transferred to the server when a data channel is active or open.This may be based on a preconfigured schedule or may be pushedautomatically. Additionally, if the client-side reporting agent fails tosend an expected record within a preconfigured time frame (e.g.,twenty-four hours), the server may attempt to open a connection retrieveany records.

Reporting and Usage Analytics Component: A reporting and usage analyticscomponent can collect information from the lockbox 100 and provide thisinformation to the server. Software executing on a remote computer mayaccess the reported information to produce reports that operators canuse for analyzing usage of the lockbox 100.

In summary, Table 1 below is an exemplary list of components of thelockbox 100, their function(s), and whether the component is associatedwith a sensor and/or an action.

Actions Sensed Component name Function Y/N? Printed circuit board (PCB)Electronic circuit used in devices to Y provide mechanical support and apathway to its electronic components. LilyGO TTGO T-SIM7000G ModuleMicro controller unit (MCU); wireless Y communications GPS AntennaReceiving and expanding radio signals N sent by distinct frequenciesfrom GPS satellites. LTE-M Antenna Sending and receiving LTE-M radio Ysignals. LTE-M (Long Term Evolution (4G), category M1) is for Internetof Things (IoT) devices to connect directly to a 4G network, without agateway and on batteries. SIM card Subscriber identity module (SIM), orY subscriber identification module (SIM), is an integrated circuitrunning a card operating system (COS) that is intended to securely storethe international mobile subscriber identity (IMSI) number and itsrelated key, which are used to identify and authenticate mobile devices.DC motor with gearbox w/locking Carousel moving and locking Y mechanismand encoder Dispense button Patient actions button Y LED Display 1.3″Human machine interface (HMI); displaying visual information. Wiring setElectrical connection. Battery pack Power supply Y Carousel plates setfor 12 slot carousels Bottles holding and movement Carousel standoffsset Carousel mounting Carousel gear Coupling between carousel and motorshaft Case open sensor Detection of case opening event Y Intrusiondetection sensor Detection of top plate removal Y Static dose coveropening detection Detection of static dose Y sensor compartment openingCase with 4-digit lid lock and bottom Physical enclosure and security ofY internal elements. Dosing door sensor Detection of takingout/returning of Y bottles Device charger Battery charging Y ChargerConnector Connection of charger to device Y TOP PLATE with maintenancekey Closing device Y Dosing Door Y Mounting set (metal parts, screwsetc) Hinges (top plate, dosing door, spare dose door)

FIG. 4 depicts a network-enabled lockbox for remote medicationsmanagement with the lid open and the static dose dispensing lids in anopen position according to an embodiment of the subject matter describedherein. Referring to FIG. 4 , carousel 400 is shown fully loaded with 12doses, a blank dosing position, and a static dose 402. The carousel 400may be rotated by means of a motor assembly 404 located below thecarousel 400. The motor assembly 404 may rotate a central shaftconnected to a central hole in the carousel 400. This allows thecarousel to be rotated such that a desired dose at a particular dosingposition can be moved beneath the primary dosing door during the DW.Outside of the DW, the blank position of the carousel, where no dose islocated, may be positioned beneath the primary dosing door. At eachsubsequent DW, a next dose may be moved beneath the primary dosing door.

In another embodiment, the dosing door may be configured to rotate overthe carousel such that a desired dose at a particular dosing positioncan be moved beneath the primary dosing door during the DW. In such anembodiment the dosing door may be installed on a circular plate androtated by the motor assembly over a fixed carousel.

In another embodiment, the carousel 400 (or components thereof) may bemanufactured using 3D printing or other additive manufacturingtechniques. 3D printing may allow for per-carousel customizations thatare not economically feasible using other manufacturing techniques suchas die- or laser-cutting sheets of metal.

FIG. 5 depicts a perspective view of a network-enabled lockbox assemblywith the entire top plate removed thereby exposing the subdividedinterior portions of the assembly according to an embodiment of thesubject matter described herein.

The network-enabled lockbox assembly shown in FIG. 5 may include aninterior volume that is subdivided into several smaller volumes. Forexample, the carousel 400 may be located in a carousel portion 500, thestatic dose 402 may be located in a static dose portion 502, and variouselectronics may be located in an electronics portion 504.

The carousel 400 may include a plurality of dosing positions 506 thatare loaded with a corresponding number of vials. After initial loadingand before the first dose is taken, each of the vials in the dosingpositions 506 may contain a dose. At each DW, the patient removes avial, consumes the dose of the controlled substance contained therein,and replaces the empty vial to the same dosing position in the carousel.Thus, dispensing on the number of doses previously consumed, the vialsshown in FIG. 5 may contain a varying number of actual doses. Here, thecarousel includes 12 dosing positions 506 and a blank position 508.While the blank position 508 is optional, the blank position providesfor additional security because the carousel 400 may be rotated betweenDWs such that the blank position 508 is located beneath the primarydosing door. Therefore, in the event that the primary dosing door isopened outside of a DW, the user cannot gain access to a vial/dose.

In another embodiment, each position 506 in the carousel 400 could holdmultiple pills in a holder. The holder could be configured to count andreport, to the device 100, a number of pills dispensed and a number ofpills remaining. By allowing for a variable number of pills in eachdosing position 506, the dosing schedule for a patient may be moreflexible and customized than a configuration in which a single pill islocated in each dosing position 506. The holder may count and report thenumber of pills, for example, using a camera sensor and/or a weightsensor to either visually identify the number of pills or to compare aweight of the pills remaining with known values of the initial weight ofthe pills in the holder and the weight of each pill individually.

In one embodiment, sensors are configured to directly detect what isdispensed rather than inferring what is dispensed based on detecting thepresence or absence of a physical object such as a vial or bottle. Forexample, in contrast to simply detecting that a bottle containing 5 mlof liquid was removed from the carousel during the dosing window andthen replaced back to the carousel, thereby inferring that the 5 ml ofliquid (dose) was consumed, in some embodiments the presence or absenceof the liquid dose in the bottle can be directly detected. In oneexample, this may include using a weight sensor for comparing the weightof the bottle before and after being removed from the carousel duringthe dosing window. A preconfigured weight for the bottle and the liquidmay be used to determine whether the liquid was consumed. In anotherexample, a camera sensor may visually detect a volume of liquid in thebottle. This may be easiest when a clear bottle and a colored liquid areused. Other types of direct detection sensors may also be used withoutdeparting from the scope of the subject matter described herein.

It is appreciated that the various sensors in the network-enabledlockbox may communicate internally with other sensors and/or withexternal devices such as the remote server or a mobile phone. Forexample, multiple weight sensors, motion sensors, etc. may communicatewith other sensors of the same type or different types.

FIG. 6 depicts a perspective view of the carousel, motor, and worm driveassembly connected to an interior frame where the assembly is loadedwith doses and a static dose according to an embodiment of the subjectmatter described herein.

The loaded carousel and frame assembly 400 shown in FIG. 6 includes afirst frame portion 602 for affixing or attaching to an interior wall ofthe lockbox 100 when inserted into the body 102. For example, the firstframe portion 602 can be secured, affixed, or attached to the body 102using one or more screws. This allows the carousel and frame assembly400 to be assembled outside of the lockbox 100 and either removed orinserted into a lockbox 100 quickly and conveniently.

On the opposite side of the carousel, the carousel and frame assembly600 includes a second frame portion 604 for affixing or attaching to aninterior wall of the lockbox 100 when inserted into the body 102.Additionally, various components such as the motor, battery,communications subsystem, and/or control electronics may be attached tothe second frame portion 604. This separates and divides the interiorcompartment space of the lockbox 100 to prevent tampering with thesevarious components in the event that an unauthorized user gained accessto the carousel portion of the lockbox 100.

Attached to the second frame portion 604 may be a static dosecompartment 606 for storing a static dose. For example, the static dosecompartment 606 may be a metal or plastic box with an open top portionthat is sized to fully contain the static dose. When assembled with thetop plate 200, the static dose access port lid 310 may be locateddirectly above the open portion of the static dose compartment 606. Thestatic dose can function as the either: 1) the last dose of a cycle; or,2) as an emergency or safety dose such that the user still may obtain adose in the event of a device malfunction, missing regular dose, orother issue.

FIG. 7 depicts a perspective view of an empty carousel, motor, and wormdrive without an internal frame according to an embodiment of thesubject matter described herein. The electric motor 702 is connected toan input shaft of the worm drive 704, a battery (not shown), and controlelectronics (not shown). The electric motor 702 is powered by thebattery and drives the input shaft based on instructions from thecontrol electronics. The worm drive 704 converts the rotational force ofthe input shaft to a rotational force of an output shaft 706. The outputshaft 706 of the worm drive 704 may be vertically oriented and locatedwithin a central hole of the carousel 400. It is appreciated that inother embodiments, not shown, the worm drive 704 may instead include astepper motor and gear and/or a plurality of braking solenoids. The wormdrive 704 may, however, be cheaper and easier to manufacture than astepper motor because the worm drive 704 does not need separate gearingand encoding components. Additionally, the worm gear ratio preventscarousel turning when the motor is not energized, removing cost ofbraking solenoids and alignment issues of the carousel in operation withthe braking solenoids.

The carousel 400 includes a top plate 708 and a bottom plate 710, eachcomprising a circular disc of a solid, rigid material.

The bottom plate 710 has an inner diameter and an outer diameter where asolid material is located between the inner and outer diameters. Thebottom plate 710 also has a plurality of screw holes 712 for receiving aplurality of standoff screws 714 that securely attach the bottom plate710 to the top plate 708 in a parallel configuration where the bottomplate 710 to the top plate 708 are distanced from one another by thelength of the standoff screws 714.

The top plate 708 has also an inner diameter and an outer diameter wherea solid material is located between the inner and outer diameters. Inthe example embodiment shown in FIG. 7 , the outer diameters of the topplate 708 is the same or substantially the same as the outer diameter ofthe bottom plate 710. However, the inner diameter of the top plate 708may be smaller than the inner diameter of the bottom plate 710 becausethe inner diameter of the top plate 708 is configured for receiving theoutput shaft from the worm drive 704.

The top plate 708 is also composed of a solid material located betweenthe inner and outer diameters. In contrast to the bottom plate 710, thetop plate 708 may include additional supports or solid materialconnecting an outer ring to a central hole. In one embodiment, the innerdiameter of the top plate 708 may correspond to the diameter of thecentral hole for receiving the output shaft. In another embodiment, theinner diameter of the top plate 708 may be the same as the innerdiameter of the bottom plate 710, with one or more connecting portionsof the top plate 708. These connecting portions of the top plate 708 maybe formed by removing solid material from the top plate 708 to create,for example, three roughly triangular and equally spaced openings thatleave behind three roughly straight and equally spaced supports.

While the bottom plate 710 may be substantially solid between the innerand outer diameters, the top plate 708 includes a plurality of holes.Located between the inner and outer diameters of the top plate 708,there are a plurality of non-overlapping dispensing positions. Eachdispensing position, except one, includes a hole in the top plate 708for receiving, holding, storing, or securing a dose of the controlledsubstance. The remaining dispensing position is a blank position. Theremay be no hole in the top plate 708 located at the blank position. Thedispensing positions may be equally spaced from each other. For example,the capacity of the carousel 400 may be 12 doses (plus one static dosethat is located outside of the carousel and discussed later). Therotating carousel 400 can include one blank position which can be filledwith a stub. The blank position, if configured, may be exposed invarious conditions. For example, the blank position may be exposed afterthe carousel 400 refilled, before the first dose, and/or between doses.The top plate 708 may also include a plurality of screw holes 712 forreceiving a plurality of standoff screws 714 for securely attaching thetop plate to the bottom plate 710.

FIG. 8 depicts an exploded perspective view of an alternativeconfiguration of an empty carousel, motor, and worm drive without aninternal frame according to an embodiment of the subject matterdescribed herein. In the embodiment shown, various components may be cutfrom sheets of aluminum. This may be easier to manufacture than othertechniques. Carousel cover 300 may include a cutout portion for passinga dose from within the carousel to the user during a dosing window. Topplate 708 may include a plurality of circular cutouts corresponding todosing positions for storing bottles of the controlled substance. Thebottoms of the bottles of the controlled substance may be supported andslide on a middle plate 800. The middle plate 800 may be secured to alower plate 802 via rotatable central shaft 804. A rotating bottomsupport plate 802 may avoid issues like sticking and be more compatiblewith “deactivation” schemes. The bottom two plates 800, 802 create wellsfor the bottle bottoms by having a ring-shaped plate with cut holesaffixed flush above a solid ring. The two bottom plates 800, 802 aresuspended by a series of standoffs similar to those shown as elements714, where these standoffs rotate as integral components of thecarousel. The carousel shown may be substantially cheaper to manufacturethan other embodiments (i.e., less than $20), weigh less than one pound,and may be easily reconfigured to accommodate variable number ofcontainers as well as containers of varying height and width.

FIG. 9 depicts a network diagram illustrating exemplary communicationsbetween devices according to an embodiment of the subject matterdescribed herein. The network-enabled lockbox 100 communicate with otherdevices using one or more networks and/or network protocols.Communications between the lockbox 100 and external devices may behandled by the communications subsystem in the lockbox 100. Thecommunications subsystem communicates data between the plurality ofsensors and/or the control electronics and a backend server or a mobiledevice. Typically, data is read from sensors and reported to an externaldevice (e.g., backend server 902) while data is received from anexternal device for controlling various physical aspects of the lockbox100, such as remotely locking the lockbox 100. The communicationssubsystem includes a Wi-Fi device for communicating with nearby digitaldevices to exchange data by radio waves via IEEE 802.11 wireless networkprotocols, a cellular radio for communicating wirelessly with cellularnetwork towers, and a Bluetooth device for exchanging data between overshort distances using UHF radio waves in the ISM bands from 2.402 GHz to2.48 GHz.

The lockbox 100 may communicate, via network 800, with a backend server902. Network 900 may include any combination of wired or wirelessnetworks, such as a Wi-Fi router connected to the internet or a cellulartower connected to the internet. The backend server 902 may storereporting and analytics information for lockbox 100.

In general, the network 900 and/or, over which the client devices, theserver 902 communicate, may be a cellular network, a broadband network,a telephonic network, an open network, such as the Internet, or aprivate network, such as an intranet and/or the extranet, or anycombination thereof. For example, the Internet can provide filetransfer, remote log in, email, news, RSS, cloud-based services, instantmessaging, visual voicemail, push mail, VoIP, and other services throughany known or convenient protocol, such as, but is not limited to theTCP/IP protocol, UDP, HTTP, DNS, FTP, UPnP, NSF, ISDN, PDH, RS-232, SDH,SONET, etc.

The network 900 and/or can be any collection of distinct networksoperating wholly or partially in conjunction to provide connectivity tothe client devices 100, 904, 906 and the server 902 and may appear asone or more networks to the serviced systems and devices 100, 904, 906.In one embodiment, communications to and from the client devices 100,904, 906 can be achieved by, an open network, such as the Internet, or aprivate network, broadband network, such as an intranet and/or theextranet. In one embodiment, communications can be achieved by a securecommunications protocol, such as secure sockets layer (SSL), ortransport layer security (TLS).

Communications can be achieved via one or more networks 1000, such as,but are not limited to, one or more of WiMax, a Local Area Network(LAN), Wireless Local Area Network (WLAN), a Personal area network(PAN), a Campus area network (CAN), a Metropolitan area network (MAN), aWide area network (WAN), a Wireless wide area network (WWAN), or anybroadband network, and further enabled with technologies such as, by wayof example, Global System for Mobile Communications (GSM), PersonalCommunications Service (PCS), Bluetooth, WiFi, Fixed Wireless Data, 2G,2.5G, 3G (e.g., WCDMA/UMTS based 3G networks), 4G, IMT-Advanced, pre-4G,LTE Advanced, mobile WiMax, WiMax 2, WirelessMAN-Advanced networks,enhanced data rates for GSM evolution (EDGE), General packet radioservice (GPRS), enhanced GPRS, iBurst, UMTS, HSPDA, HSUPA, HSPA, HSPA+,UMTS-TDD, 1×RTT, EV-DO, messaging protocols such as, TCP/IP, SMS, MMS,extensible messaging and presence protocol (XMPP), real time messagingprotocol (RTMP), instant messaging and presence protocol (IMPP), instantmessaging, USSD, IRC, or any other wireless data networks, broadbandnetworks, or messaging protocols.

All communications may be initiated from the lockbox 100. The lockbox100 may initiate communications that are “event” driven. Example eventsinclude: a dosing event, a dosing finished event, a dosing skippedevent, a sensor threshold alarm, a shock event (e.g., free fall), a caseopened event, and GPS activity.

In the absence of an event, communication between the lockbox 100 andthe server 902 may be done with heartbeats. Heartbeats may bepre-scheduled and sent from the lockbox 100. The server 902 may be awareof the heartbeat schedule for the lockbox 100. A missed heartbeat may beinterpreted by the server 902 as an indication that the remote lockbox100 may have a problem, such as lack of communication and/or power or asecurity breach. A heartbeat may include local status and environmentaldata (e.g., temperature, humidity, location, battery state). Inresponse, the lockbox 100 may receive status from the server 902 (forexample, if a “lock” command is sent from the server 902 to the lockbox100, the lockbox 100 will lock).

The client devices 100, 904, 906 can be any system and/or device, and/orany combination of devices/systems that is able to establish aconnection, including wired, wireless, cellular connections with anotherdevice, a server and/or other systems such as server. Client devices100, 904, 906 typically include a display and/or other outputfunctionalities to present information and data exchanged between amongthe devices 100, 904, 906 and/or the server 902.

For example, the client device 906 can include mobile, hand held orportable devices, wireless devices, or non-portable devices and can beany of, but not limited to, a server desktop, a desktop computer, acomputer cluster, or portable devices, including a notebook, a laptopcomputer, a handheld computer, a palmtop computer, a mobile phone, acell phone, a smart phone, a PDA, a Blackberry device, a Palm device,any tablet, a “phablet” (a class of smart phones with larger screensizes between a typical smart phone and tablet), a handheld tablet(e.g., an iPad, the Galaxy series, the Nexus, the Kindles, Kindle Fires,any Android-based tablet, Windows-based tablet, Amazon e-Readers orother readers, or any other tablet), any portable readers/readingdevices, a hand held console, a hand held gaming device or console, ahead mounted device, a head mounted display, a thin client or anySuperPhone such as the iPhone, and/or any other portable, mobile, handheld devices, or fixed wireless interface such as a M2M device, etc. Inone embodiment, the client devices (or mobile device), host server, andapplication server are coupled via a network and/or a network. In someembodiments, the devices and host server may be directly connected toone another.

As referred to herein, the term “computing device” should be broadlyconstrued. Examples would include a smart phone, a cell phone, a pager,a personal digital assistant (PDA, e.g., with GPRS NIC), a mobilecomputer with a cellular radio, or the like. A typical computing deviceis a wireless data access-enabled device (e.g., an iPHONE® smart phone,a BLACKBERRY® smart phone, a NEXUS ONE™ smart phone, an iPAD™ device, orthe like) that is capable of sending and receiving data in a wirelessmanner using protocols like the Internet Protocol, or IP, and thewireless application protocol, or WAP. This allows users to accessinformation via wireless devices, such as smart phones, mobile phones,pagers, two-way radios, communicators, and the like. Wireless dataaccess is supported by many wireless networks, including, but notlimited to, CDPD, CDMA, GSM, PDC, PHS, TDMA, FLEX, ReFLEX, iDEN, TETRA,DECT, DataTAC, Mobitex, EDGE and other 2G, 3G, 4G and LTE technologies,and it operates with many handheld device operating systems, such asPalmOS, EPOC, Windows CE, FLEXOS, OS/9, JavaOS, iOS and Android.Typically, these devices use graphical displays and can access theInternet (or other communications network) on so-called mini- ormicro-browsers, which are web browsers with small file sizes that canaccommodate the constrained operating environment of wireless devices onwireless networks. In a representative embodiment, the computing deviceis a cellular telephone or smart phone that operates over GPRS (GeneralPacket Radio Services), which is a data technology for GSM networks. Inaddition to a conventional voice communication, a given computing devicecan communicate with another such device via many different types ofmessage transfer techniques, including SMS (short message service),enhanced SMS (EMS), multi-media message (MMS), email WAP, paging, orother known or later-developed wireless data formats. Although many ofthe examples provided herein are implemented on a computing device, theexamples may similarly be implemented on any suitable “computingdevice”. An imaging device is any computing device operable to take orreceive image data.

Initial Setup and Carousel Loading:

Device Setup: This may include physical assembly of the lockbox 100 bythe manufacturer. As stated above, the internal frame and the carouselassembly, including the motor, battery, communications subsystem,control electronics etc. can be assembled outside of the lockbox body102. The internal frame can be inserted into the body 102 and securedtherein. The top plate 200 can then be added and secured, and the lid104 attached to the body 102 and secured with lock 106.

Unique device ID: This may include assigning an identifier, such as analphanumeric sequence, serial number, bar code, or QR code, thatuniquely identifies a particular lockbox 100 from all other lockboxes.The unique device ID may be etched into the lockbox 100 itself, may beencoded into a memory in the lockbox 100, and may also be stored in adatabase associated with backend server 902.

Load Firmware: This may include installing the firmware permanently suchthat it cannot be changed after manufacture or may include programming arewritable media after manufacture. Firmware is a type of software thatis etched directly into a piece of hardware. It operates without goingthrough APIs, the operating system, or device drivers—providing theneeded instructions and guidance for the device to communicate withother devices or perform a set of basic tasks and functions as intended.Thus, firmware is a specific class of computer software that providesthe low-level control for a device's specific hardware. Firmware maycontain basic functions of a device and may provide hardware abstractionservices to higher-level software such as operating systems. For lesscomplex devices, firmware may act as the device's complete operatingsystem, performing all control, monitoring and data manipulationfunctions. Firmware is held in non-volatile memory devices such as ROM,EPROM, EEPROM, and Flash memory. Updating firmware requires ROMintegrated circuits to be physically replaced, or EPROM or flash memoryto be reprogrammed through a special procedure. Some firmware memorydevices are permanently installed and cannot be changed aftermanufacture.

Load SIM: This may include the initial programming of the SIM card tofunction with a particular cellular network provider and/or physicalinsertion of the programmed SIM card into an appropriate SIM card slotin the communications subsystem of the lockbox 100. A mobile networkvirtual operator (MVNO) may be used for IoT communications associatedwith the SIM cards. An MVNO is wireless communications services providerthat does not own the wireless network infrastructure over which itprovides services to its customers, and instead connects paired SIMcards to the best available network connection. Using an MVNO maysignificantly increase device connectivity across multiple geographies.

Run verification and validation (V&V): This may include procedures forchecking that the network-enabled lockbox 100 and any associated frontend or back-end software services and/or systems meet requirements andspecifications and, further, that the network-enabled lockbox 100fulfills its intended purpose of securely dispensing controlledsubstances. Verification checks that the network-enabled lockbox 100meets a set of design specifications. In the development phase,verification procedures may involve performing special tests to model orsimulate a portion, or the entirety, of the network-enabled lockbox 100and then performing a review or analysis of the modeling results. In thepost-development phase, verification procedures may involve regularlyrepeating tests devised specifically to ensure that the network-enabledlockbox 100 continues to meet the initial design requirements,specifications, and regulations as time progresses. Validation ensuresthat the network-enabled lockbox 100 (or portion thereof) meets theoperational needs of the user. Tested attributes in validation tasks mayinclude, but are not limited to, sensitivity and specificity, accuracyand precision, repeatability, reproducibility, and suitability of thenetwork-enabled lockbox 100. Suitability tests the network-enabledlockbox 100 as a whole and is based on the concept that the equipment,electronics, and analytical operations constitute an integral systemthat can be evaluated as such.

Create Birth Certificate: This may include locating, identifying,scanning, or otherwise determining birth information for the patient.This information can be stored in a database associated with the backend server 902.

Charge Battery: This may include plugging the battery into an externalpower source in order to fully charge the battery. A single, full chargeof the battery may allow the lockbox to operate the completefunctionality of its sensors, communications subsystem, and controlelectronics for at least as long as the number of doses in the carousel.This allows a patient to use the lockbox for the entire two week periodwithout having to plug in the device. However, in other embodiments, thebattery may be larger or smaller such that a full charge lasts less thanthe two-week example dosing schedule. This may be because, for example,the weight of the battery is too heavy for a particular user or use caseand there is sufficient external power to recharge the battery on-siteor the electrical load produced by the sensors, communicationssubsystem, and control electronics exceeds an estimated amount such thatthe battery drains faster than estimated as well.

Assign to Customer: This may include assigning a particularnetwork-enabled lockbox 100 to a particular patient or may includeassigning multiple network-enabled lockboxes 100 to a particular clinicor dispensary. In either case, identifiers associated with either theclinic or the patient may be associated in a database with identifiersassociated with one or more network-enabled lockboxes 100.

Device Configuration at Clinic: This may include loading a patientprofile into memory, storage, or firmware of the network-enabled lockbox100.

Connect to power: This may include plugging the battery into an externalpower source to fully charge the battery.

Assign to internal entity (e.g., Clinic #1): This may includeassociating the unique device ID with an identifier for a particularclinic or dispensary within a database.

Assign to Patient: This may include associating various data with apatient identifier in a database. The data may include a patient profilewhich is a collection of data associated with the patient. By organizingpatient data into a patient profile, the data may be more easily andsecurely stored and handled. For example, a patient profile may betransferred from one client to another in the event that the patientmoves. The patient profile may be transferred from a clinic computer tothe lockbox 100 assigned to the patient. The patient profile may bemodified at any time by authorized personnel. The patient profile mayinclude, but is not limited to, the Patient ID, any prescriptions thepatient is taking or has taken, dosing windows, and security rules.

The patient profile may also provide for inheritance in that some datawithin the patent profile (an object or class) may be based upon anotherobject (prototype-based inheritance) or class (class-based inheritance),retaining similar implementation. Patient profile inheritance alsoprovides for deriving new classes (i.e., sub classes) from existingclasses and then forming them into a hierarchy of classes. In thepatient profile, an object created through inheritance, a “childobject”, may acquire all the properties and behaviors of the “parentobject”.

Set user combination and record in database: This may include defining acode for locking and unlocking the built-in lock on a given lockbox 100.For example, a four-digit combination lock may be assigned a code 1234.The code assigned to the lockbox 100 may be stored in a databaseassociated with back-end server 902.

Patient Ready V&V: This may include procedures for checking that thenetwork-enabled lockbox 100 is ready to be given to the patient. Forexample, the patient may test that the built-in lock on thenetwork-enabled lockbox 100 opens when the preconfigured code isentered. Similarly, the patient may test that the primary dispensingdoor opens when a test DW occurs.

Device Load/Unload at Clinic Dispensary: This may include placing thedesired number of doses of the controlled substance into the desirednumber and locations within the carousel. For example, a carouselcontaining 12 regular dosing positions in the carousel and 1 static doselocation in the static dose compartment may be loaded with 14 totaldoses such that every available dosing position is loaded. In anotherembodiment, the same carousel may be loaded with fewer doses than thereare dosing positions. For example, 7 doses may be loaded in the12-position carousel. This may be accomplished, for example, by loadingall 7 doses sequentially starting at the first position or by loadingeach of the 7 doses in every other position. In either embodiment, it isappreciated that the software controlling the control electronics andfor alerting the server 902 of various states of the lockbox 100 (e.g.,dose taken, dose skipped, etc.) may require knowledge of the number andpositions of the loaded doses within the carousel. This may be requiredin order to avoid misinterpretation by the lockbox 100 of a skipped dosewhen the carousel opens on an empty position that the software expectsto be a loaded position. In other cases, the carousel may be programmedto skip a position each DW such that empty positions are skippedautomatically. Again, this should be done in coordination with thereporting and analytics software. The loaded carousel and it associatedcomponents (motor, electronics, etc.) may be secured within thenetwork-enabled lockbox 100 and the top plate and the lid may besecured.

Authenticate dispensary: This may include verifying information by theclinic or dispensary with a third-party in order to ensure that theentity loading the device is authenticated and authorized. If thedispensary were not authenticating, then a user could produce falsereporting and analytics data regarding loading, unloading, dosingwindows, etc.

Transfer assignment to dispensary: This may include transferringauthority and control of the network-enabled lockbox 100 from themanufacturer to the clinic or dispensary.

Put in “load/unload mode” (Suspends security model): This may includethe clinician or administrator temporarily suspending the normalsecurity model that would otherwise alert of physical tampering ofnetwork-enabled lockbox 100 (e.g., removing the top plate, the carouselcover, or the carousel) in order to load or unload vials and/or thecarousel.

Present patient prescription/order details to dispensary staff: This mayinclude the patient providing prescription details regarding thecontrolled substance to be dispensed to dispensary staff. Theprescription or order details may be provided electronically or onpaper.

Open with key and Load/Unload: This may include opening the lid and/orthe top plate using a key. The patient does not have access to this key.The patient gains access to the interior of the network-enabled lockbox100 using a keyless lock and gains access to a vial using the primarydispending door. An administrator, however, may unlock the carouselcover 300 using a key to unlock keyed lock 304. This allows access tothe entire carousel portion 500 for loading new vials and unloading usedvials from the carousel 400.

FIG. 10 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary activity tiles design for an administrative dashboardaccording to an embodiment of the subject matter described herein.Referring to FIG. 10 , a user interface (UI) (e.g., a graphical userinterface (GUI) or a command line interface) includes front end softwarefor monitoring and administering one or more network-enabled lockboxes.FIG. 10 shows a wireframe illustration of a software visual interface(screen) for the administrator's view to the software. The interfaceincludes a plurality of “activity tiles”. Clicking on each activity tileopens a new, relevant window. The software is accessed by providerpersonnel having different roles in patient care. In one embodiment,there are dashboards tailored to each role. In one example role-functionmatrix, the dispensing nurse or pharmacists will have the primary rolefor software interactions.

Dashboard 1000 includes a “create profile” activity tile 1002, a“patient lookup” activity tile 1004, a “dose protocol” activity tile1006, a “geofence” activity tile 1008, a “device loading” activity tile1010, and a “device status” activity tile 1012. These tiles are not allrequired and additional tiles may be included in dashboard 1000 withoutdeparting from the scope of the subject matter described herein. The“create profile” activity tile 1002 allows an administrator to create anew patient profile. The patient profile may include information such aspatient ID, home address, phone number, email address, case number,doctor, device ID, and device lock code. The “patient lookup” activitytile 1004 allows an administrator to search for a patient based onpatient ID or other information in a patient profile. The “doseprotocol” activity tile 1006 allows an administrator to view and managea patient's medication, medication amount, and medication schedule. The“geofence” activity tile 1008 allows an administrator to identify andmanage a geographical area within which a device 100 may be allowed ordisallowed. If a device 100 leaves a geofenced area, an alert may beautomatically generated and reported. The “device loading” activity tile1010 allows an administrator to suspend various security and alertingmeasures that may be operable when the device is loaded and at home withthe patient so that the device 100 can be loaded with doses withoutcausing excessive or unnecessary alerts. The “device status” activitytile 1012 allows an administrator to view and manage various hardwarestatuses of the device 100 such as sensor data, battery levels,connected communications networks, etc.

FIG. 11 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary click-through result from the “Create Patient Profile”activity tile of FIG. 10 according to an embodiment of the subjectmatter described herein. As mentioned above, the patient profile mayinclude information such as patient ID, home address, phone number,email address, case number, doctor, device ID, and device lock code.

FIG. 12 depicts a graphical user interface for software executing on acomputing device other than the network-enabled lockbox illustratingexemplary reporting, analytics, and administrative functions accordingto an embodiment of the subject matter described herein. Referring toFIG. 12 , a user interface (UI) (e.g., a graphical user interface (GUI)or a command line interface) includes front end software for monitoringand administering one or more network-enabled lockboxes.

In a status summary portion 1200 of the UI, patient information may bedisplayed. The patient information may include some or all of thepatient profile. The status of multiple patients may be displayed byselecting from among one or more dots, where a green dot may indicate anactive patient and a red dot may indicate an inactive patient.

In a remote inventory portion 1202 of the UI, an illustration of aselected carousel may be displayed showing the dosing positions (labeled0-14) where each dosing position may be colored to indicate a differentstatus. For example, a dosing position may be colored grey (e.g., 0 and5-14) to indicate that no dose is located at the position (e.g.,previously consumed). A dosing position may be colored green (e.g., 2-4)to indicate that a dose is located at the position (e.g., not yetconsumed). A dosing position may be colored red (e.g., 1) to indicatethat the dose is the last dose. It is appreciated that in the embodimentshown, the first dose consumed during the first DW may correspond todosing position 14 (assuming that position 0 is a blank position) andeach successive DW may correspond to the next dosing position indecreasing order (e.g., 12, 11, 10 . . . ). Alternatively, however, thefirst dose consumed during the first DW may correspond to dosingposition 1 (assuming that position 0 is a blank position) and eachsuccessive DW may correspond to the next dosing position in increasingorder (e.g., 2, 3, 4, . . . ) without departing from the scope of thesubject matter described herein.

In an event log portion 1204 of the UI, a record or history of alerts orevents associated with a particular device ID may be displayed.Typically, the event log is presented in chronological order. However,the events in the event log may also be filtered and/or sorted by othermetrics such as alphabetically, by type, date ranges, or manuallysearched.

In a remote lock/unlock portion 1206 of the UI, an administrator maydetermine whether a device is in a locked or unlocked state, asdetermined by one or more sensors located in the device. Theadministrator may also remotely lock or unlock the device by clicking abutton in the interface. Additional security measures may be required,such as entering the device lock code associated with the patientprofile for the device and/or an administrator login or confirmationbefore the remote lock/unlock request is performed.

The subject matter disclosed herein may be executed on a machine(computer system) within which a set of instructions, for causing themachine to perform any one or more of the methodologies discussedherein. The computer system includes a processor, memory, non-volatilememory, and an interface device. Various common components (e.g., cachememory) are omitted for illustrative simplicity. The computer system canbe of any applicable known or convenient type.

The components of the computer system can be coupled together via a busor through some other known or convenient device. The processor may be,for example, a conventional microprocessor such as an Intel Pentiummicroprocessor or Motorola power PC microprocessor. One of skill in therelevant art will recognize that the terms “machine-readable (storage)medium” or “computer-readable (storage) medium” include any type ofdevice that is accessible by the processor. The memory is coupled to theprocessor by, for example, a bus. The memory can include, by way ofexample but not limitation, random access memory (RAM), such as dynamicRAM (DRAM) and static RAM (SRAM). The memory can be local, remote, ordistributed.

Software is typically stored in the non-volatile memory and/or the driveunit. Indeed, for large programs, it may not even be possible to storethe entire program in the memory. Nevertheless, for software to run, ifnecessary, it is moved to a computer readable location appropriate forprocessing, and for illustrative purposes, that location is referred toas the memory in this paper. Even when software is moved to the memoryfor execution, the processor typically make use of hardware registers tostore values associated with the software, and local cache that,ideally, serves to speed up execution. As used herein, a softwareprogram is assumed to be stored at any known or convenient location(from non-volatile storage to hardware registers) when the softwareprogram is referred to as “implemented in a computer-readable medium.” Aprocessor is “configured to execute a program” when at least one valueassociated with the program is stored in a register readable by theprocessor.

In operation, the computer system can be controlled by operating systemsoftware that includes a file management system, such as a diskoperating system. One example of operating system software withassociated file management system software is the family of operatingsystems known as Windows® from Microsoft Corporation of Redmond, Wash.,and their associated file management systems. Another example ofoperating system software with its associated file management systemsoftware is the Linux operating system and its associated filemanagement system. The file management system is typically stored in thenon-volatile memory and/or drive unit and causes the processor toexecute the various acts required by the operating system to input andoutput data and to store data in the memory, including storing files onthe non-volatile memory and/or drive unit.

The bus may couple the processor to the non-volatile memory and driveunit. The non-volatile memory is often a magnetic floppy or hard disk, amagnetic-optical disk, an optical disk, a read-only memory (ROM), suchas a CD-ROM, EPROM, or EEPROM, a magnetic or optical card, or anotherform of storage for large amounts of data. Some of this data is oftenwritten, by a direct memory access process, into memory during executionof software in the computer. The non-volatile storage can be local,remote, or distributed. The non-volatile memory is optional becausesystems can be created with all applicable data available in memory. Atypical computer system usually include at least a processor, memory,and a device (e.g., a bus) coupling the memory to the processor.

The bus may couple the processor to the network interface device. Theinterface can include one or more of a modem or network interface. Itwill be appreciated that a modem or network interface can be consideredto be part of the computer system. The interface can include an analogmodem, ISDN modem, cable modem, token ring interface, satellitetransmission interface (e.g., “direct PC”), or other interfaces forcoupling a computer system to other computer systems. The interface caninclude one or more input and/or output devices. The I/O devices caninclude, by way of example but not limitation, a keyboard, a mouse orother pointing device, disk drives, printers, a scanner, and other inputand/or output devices, including a display device. The display devicecan include, by way of example but not limitation, a cathode ray tube(CRT), liquid crystal display (LCD), or some other applicable known orconvenient display device. For simplicity, it is assumed thatcontrollers of any devices not depicted in the Figures reside in theinterface.

Some portions of the detailed description may be presented in terms ofalgorithms and symbolic representations of operations on data bitswithin a computer memory. These algorithmic descriptions andrepresentations are the means used by those skilled in the dataprocessing arts to most effectively convey the substance of their workto others skilled in the art. An algorithm is here, and generally,conceived to be a self-consistent sequence of operations leading to adesired result. The operations are those requiring physicalmanipulations of physical quantities. Usually, though not necessarily,these quantities take the form of electrical or magnetic signals capableof being stored, transferred, combined, compared, and otherwisemanipulated. It has proven convenient at times, principally for reasonsof common usage, to refer to these signals as bits, values, elements,symbols, characters, terms, numbers, or the like.

It should be borne in mind, however, that all of these and similar termsare to be associated with the appropriate physical quantities and aremerely convenient labels applied to these quantities. Unlessspecifically stated otherwise as apparent from the following discussion,it is appreciated that throughout the description, discussions utilizingterms such as “processing” or “computing” or “calculating” or“determining” or “displaying” or the like, refer to the action andprocesses of a computer system, or similar electronic computing device,that manipulates and transforms data represented as physical(electronic) quantities within the computer system's registers andmemories into other data similarly represented as physical quantitieswithin the computer system memories or registers or other suchinformation storage, transmission or display devices.

The algorithms and displays presented herein are not inherently relatedto any particular computer or other apparatus. Various general purposesystems may be used with programs in accordance with the teachingsherein, or it may prove convenient to construct more specializedapparatus to perform the methods of some embodiments. The requiredstructure for a variety of these systems will appear from thedescription below. In addition, the techniques are not described withreference to any particular programming language, and variousembodiments may thus be implemented using a variety of programminglanguages.

In alternative embodiments, the machine operates as a standalone deviceor may be connected (e.g., networked) to other machines. In a networkeddeployment, the machine may operate in the capacity of a server or aclient machine in a client-server network environment, or as a peermachine in a peer-to-peer (or distributed) network environment.

The machine may be a server computer, a client computer, a personalcomputer (PC), a tablet PC, a laptop computer, a set-top box (STB), apersonal digital assistant (PDA), a cellular telephone, an iPhone, aBlackberry, a processor, a telephone, a web appliance, a network router,switch or bridge, or any machine capable of executing a set ofinstructions (sequential or otherwise) that specify actions to be takenby that machine.

While the machine-readable medium or machine-readable storage medium isshown in an exemplary embodiment to be a single medium, the term“machine-readable medium” and “machine-readable storage medium” shouldbe taken to include a single medium or multiple media (e.g., acentralized or distributed database, and/or associated caches andservers) that store the one or more sets of instructions. The term“machine-readable medium” and “machine-readable storage medium” shallalso be taken to include any medium that is capable of storing, encodingor carrying a set of instructions for execution by the machine and thatcause the machine to perform any one or more of the methodologies of thepresently disclosed technique and innovation.

In general, the routines executed to implement the embodiments of thedisclosure, may be implemented as part of an operating system or aspecific application, component, program, object, module or sequence ofinstructions referred to as “computer programs.” The computer programstypically comprise one or more instructions set at various times invarious memory and storage devices in a computer, and that, when readand executed by one or more processing units or processors in acomputer, cause the computer to perform operations to execute elementsinvolving the various aspects of the disclosure.

Moreover, while embodiments have been described in the context of fullyfunctioning computers and computer systems, those skilled in the artwill appreciate that the various embodiments are capable of beingdistributed as a program product in a variety of forms, and that thedisclosure applies equally regardless of the particular type of machineor computer-readable media used to actually effect the distribution.

Further examples of machine-readable storage media, machine-readablemedia, or computer-readable (storage) media include but are not limitedto recordable type media such as volatile and non-volatile memorydevices, floppy and other removable disks, hard disk drives, opticaldisks (e.g., Compact Disk Read-Only Memory (CD ROMS), Digital VersatileDisks, (DVDs), etc.), among others, and transmission type media such asdigital and analog communication links.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense, as opposed to anexclusive or exhaustive sense; that is to say, in the sense of“including, but not limited to.” As used herein, the terms “connected,”“coupled,” or any variant thereof, means any connection or coupling,either direct or indirect, between two or more elements; the coupling ofconnection between the elements can be physical, logical, or acombination thereof. Additionally, the words “herein,” “above,” “below,”and words of similar import, when used in this application, shall referto this application as a whole and not to any particular portions ofthis application. Where the context permits, words in the above DetailedDescription using the singular or plural number may also include theplural or singular number respectively. The word “or,” in reference to alist of two or more items, covers all of the following interpretationsof the word: any of the items in the list, all of the items in the list,and any combination of the items in the list.

The above detailed description of embodiments of the disclosure is notintended to be exhaustive or to limit the teachings to the precise formdisclosed above. While specific embodiments of, and examples for, thedisclosure are described above for illustrative purposes, variousequivalent modifications are possible within the scope of thedisclosure, as those skilled in the relevant art will recognize. Forexample, while processes or blocks are presented in a given order,alternative embodiments may perform routines having steps, or employsystems having blocks, in a different order, and some processes orblocks may be deleted, moved, added, subdivided, combined, and/ormodified to provide alternative or subcombinations. Each of theseprocesses or blocks may be implemented in a variety of different ways.Also, while processes or blocks are at times shown as being performed inseries, these processes or blocks may instead be performed in parallel,or may be performed at different times. Further any specific numbersnoted herein are only examples: alternative implementations may employdiffering values or ranges.

The teachings of the disclosure provided herein can be applied to othersystems, not necessarily the system described above. The elements andacts of the various embodiments described above can be combined toprovide further embodiments.

Any patents and applications and other references noted above, includingany that may be listed in accompanying filing papers, are incorporatedherein by reference. Aspects of the disclosure can be modified, ifnecessary, to employ the systems, functions, and concepts of the variousreferences described above to provide yet further embodiments of thedisclosure.

These and other changes can be made to the disclosure in light of theabove Detailed Description. While the above description describescertain embodiments of the disclosure, and describes the best modecontemplated, no matter how detailed the above appears in text, theteachings can be practiced in many ways. Details of the system may varyconsiderably in its implementation details, while still beingencompassed by the subject matter disclosed herein. As noted above,particular terminology used when describing certain features or aspectsof the disclosure should not be taken to imply that the terminology isbeing redefined herein to be restricted to any specific characteristics,features, or aspects of the disclosure with which that terminology isassociated. In general, the terms used in the following claims shouldnot be construed to limit the disclosure to the specific embodimentsdisclosed in the specification, unless the above Detailed Descriptionsection explicitly defines such terms. Accordingly, the actual scope ofthe disclosure encompasses not only the disclosed embodiments, but alsoall equivalent ways of practicing or implementing the disclosure underthe claims.

While certain aspects of the disclosure are presented below in certainclaim forms, the inventors contemplate the various aspects of thedisclosure in any number of claim forms. For example, while only oneaspect of the disclosure is recited as a means-plus-function claim under35 U.S.C. § 112, ¶ 6, other aspects may likewise be embodied as ameans-plus-function claim, or in other forms, such as being embodied ina computer-readable medium. (Any claim intended to be treated under 35U.S.C. § 112, ¶ 6 begins with the words “means for”.) Accordingly, theapplicant reserves the right to add additional claims after filing theapplication to pursue such additional claim forms for other aspects ofthe disclosure.

What is claimed is:
 1. A device for remote medications managementcomprising: a plurality of vials each bearing a unique identifier and indiscrete locations in the device; an alignment assembly for aligning oneof the discrete locations with an access point for dispensing one of theplurality of vials; a computer readable memory comprising executableinstructions for selecting a vial of the plurality of vials to bedispensed; a computer readable memory configured for storing inventoryinformation of the plurality of vials, wherein the inventory informationassociates the unique identifiers with a status for each the pluralityof vials, the status selected from among the group indicating whether avial is: loaded, dispensed, returned, or remaining undispensed in thedevice; a computer readable memory comprising computer executableinstructions for deactivating dispensing of the vials from the device,wherein the instructions for deactivating dispensing are based on atleast one signal received from at least one environmental sensor,wherein the at least one environmental sensor is configured to detectone of: location, temperature, humidity, vibration, shock, blood alcoholcontent (BAC), and light intrusion; and a deactivation assembly fordeactivating dispensing of the vials based on the instructions.
 2. Thedevice of claim 1, wherein the discrete locations are fixed and theaccess point is movable.
 3. The device of claim 1, wherein the discretelocations are movable and the access point is fixed.
 4. The device ofclaim 3, wherein the movable discrete locations include storing theplurality of vials in a movable conveyor selected from the group: acarousel, a linear conveyor belt, or a serpentine conveyor belt.
 5. Thedevice of claim 1, wherein the deactivation assembly comprises a lockingmechanism for prohibiting alignment of the access point with anunauthorized discrete location, where the locking mechanism is selectedfrom the group: an escapement, a latching solenoid plunger, or a wormgear.
 6. The device of claim 1, wherein the at least one source includesone or more sensors for detecting removal and return of a vial.
 7. Thedevice of claim 6, wherein the sensors further detect if a vial is full,empty, or partially full.
 8. The device of claim 1, wherein theinstructions further comprise an additional signal received from anadditional source, the additional source being selected from the group:a user wearable, a GPS location, an onboard mobile network connection, apaired mobile device, an internet connection, a Bluetooth connection, abreathalyzer, an elapsed time measurement.
 9. The device of claim 1,wherein the instructions further comprise an additional signal receivedfrom an additional source, the additional source being selected from thegroup: an acceleration sensor, an impact sensor, and a gyroscope. 10.The device of claim 1, wherein the environmental sensor includes a GPSsensor.